Each caps ule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.

Transcription

1 VITAMIN D- ergocalciferol capsule Strides Shas un Limited VITAMIN D (Ergocalciferol Caps ules, USP) 1.25mg (50,000 USP Units) Each caps ule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. DESCRIPTION Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D 2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of , and has the following structural formula: Inactive Ingredients: FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze, N-Butyl alcohol, Simethicone, Soybean oil and Titanium dioxide. CLINICAL PHARMACOLOGY The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1, 25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal

2 tubules. There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys. INDICATIONS AND USAGE Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. CONTRAINDICATIONS Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D. WARNINGS Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted. Keep out of the reach of children. PRECAUTIONS General Vitamin D administration from fortified foods, dietary supplements, self-administered and prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon as there is clinical improvement. Dosage levels must be individualized and great care exercised to prevent serious toxic effects. IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. When high therapeutic doses are used progress should be followed with frequent blood calcium determinations. In the treatment of hypoparathyroidism, intravenous calcium, parathyroid hormone, and/or dihydrotachysterol may be required. Maintenance of a normal serum phosphorus level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders in those patients with hyperphosphatemia as frequently seen in renal osteodystrophy is essential to prevent metastatic calcification. Adequate dietary calcium is necessary for clinical response to vitamin D therapy. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Protect from light. Drug Interactions Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations. Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with Ergocalciferol Capsules, USP may cause hypercalcemia. Carcinogenes is, Mutagenes is, Impairment of Fertility

3 No long-term animal studies have been performed to evaluate the drug's potential in these areas. Pregnancy Category C Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation. For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP Units of vitamin D daily during pregnancy has not been established. Nurs ing Mothers Caution should be exercised when Ergocalciferol Capsules, USP are administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in her child. Monitoring of the infant's serum calcium concentration is required in that case (Goldberg, 1972). Pediatric Us e Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION). Geriatric Us e Clinical studies of Ergocalciferol Capsules, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A few published reports have suggested that the absorption of orally administered vitamin D may be attenuated in elderly compared to younger, individuals. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. ADVERSE REACTIONS Hypervitaminosis D is characterized by effects on the following organ system: Renal: Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death. CNS: Mental retardation. Soft Tissues: Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Skeletal: Bone demineralization (osteoporosis) in adults occurs concomitantly. Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism) vague aches, stiffness, and weakness. Gastrointestinal: Nausea, anorexia, constipation. Metabolic: Mild acidosis, anemia, weight loss. Call your doctor for medical advice about s ide effects. You may report s ide effects to Strides Pharma Inc. at or go to trides s has un.com

4 OVERDOSAGE The effects of administered vitamin D can persist for two or more months after cessation of treatment. Hypervitaminosis D is characterized by: 1. Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis. 2. Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death. 3. Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Bone demineralization (osteoporosis) in adults occurs concomitantly. 4. Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism). The treatment of hypervitaminosis D with hypercalcemia consists in immediate withdrawal of the vitamin, a low calcium diet, generous intake of fluids, along with symptomatic and supportive treatment. Hypercalcemic crisis with dehydration, stupor, coma, and azotemia requires more vigorous treatment. The first step should be hydration of the patient. Intravenous saline may quickly and significantly increase urinary calcium excretion. A loop diuretic (furosemide or ethacrynic acid) may be given with the saline infusion to further increase renal calcium excretion. Other reported therapeutic measures include dialysis or the administration of citrates, sulfates, phosphates, corticosteroids, EDTA (ethylenediaminetetraacetic acid), and mithramycin via appropriate regimens. With appropriate therapy, recovery is the usual outcome when no permanent damage has occurred. Deaths via renal or cardiovascular failure have been reported. The LD in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg. 50 DOSAGE AND ADMINISTRATION THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. Vitamin D Resistant Rickets: 12,000 to 500,000 USP Units daily. Hypoparathyroidism: 50,000 to 200,000 USP Units daily concomitantly with calcium lactate 4 g, six times per day. DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION. Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized. HOW SUPPLIED Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with '194' in white and contain clear light yellow oily liquid. Bottles of 50 capsules (NDC: ) Bottles of 100 capsules (NDC: ) Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Protect from light.

5 Manufactured by: Strides Shasun Limited Bengaluru , India. Dis tributed by: Strides Pharma Inc. East Brunswick, NJ Rx Only Revised: 05/2016 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bottle of 100 capsules Strides Pharma Inc Rx only NDC Vitamin D (Ergocalciferol Caps ules, USP) 1.25 mg* (50,000 USP Units) WARNING: DO NOT EXCEED RECOMMENDED DOSAGE Rx only 100 Caps ules VITAMIN D ergocalciferol capsule

6 Product Information Product T ype HUMAN PRESCRIPTION DRUG Ite m Code (Source ) NDC: Route of Ad minis tration ORAL Active Ing redient/active Moiety Ing redient Name Basis o f Streng th Streng th ERGO CALCIFERO L (UNII: VS0 41H42XC) (ERGOCALCIFEROL - UNII:VS0 41H42XC) ERGOCALCIFEROL 1.25 Inactive Ing redients Ing redient Name FD&C YELLO W NO. 5 (UNII: I753WB2F1M) GELATIN (UNII: 2G8 6 QN327L) GLYCERIN (UNII: PDC6 A3C0 OX) LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U) WATER (UNII: 0 59 QF0 KO0 R) ETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: IDK7C2HS0 9 ) SO YBEAN O IL (UNII: 241ATL177A) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) SHELLAC (UNII: 46 N10 7B71O) Streng th Product Characteristics Color GREEN S core no sco re Shape CAPSULE Siz e 12mm Flavor Imp rint Cod e 19 4 Contains Packag ing # Item Co de Packag e Descriptio n 1 2 NDC: NDC: in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n Pro duct 50 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n Pro duct Marketing Start Date 0 5/16 / /16 /20 14 Marketing End Date Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date ANDA ANDA /16 /20 14 Labeler - Strides Shas un Limited ( )

7 Registrant - Strides Shas un Limited ( ) Establishment Name Addre ss ID/FEI Busine ss Ope rations Strides Shasun Limited ANALYSIS( ), MANUFACTURE( ), PACK( ) Revised: 12/2016 Strides Shasun Limited